FDA 510(k)

Fujifilm Duodenoscope Model ED-530XT

Número K: K152257 · 2017-07-21

RequerenteFujifilm Medical Systems U.S.A, Inc.

Data da decisão2017-07-21

Código do produtoFDT

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Fujifilm Duodenoscope Model ED-530XT is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. It received FDA 510(k) clearance on 2017-07-21 under 510(k) number K152257. The device is classified under product code FDT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Fujifilm Duodenoscope Model ED-530XT?

Fujifilm Duodenoscope Model ED-530XT is a medical device that received FDA 510(k) clearance on 2017-07-21. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. The 510(k) number is K152257.

When did Fujifilm Duodenoscope Model ED-530XT receive FDA 510(k) clearance?

Fujifilm Duodenoscope Model ED-530XT received FDA 510(k) clearance on 2017-07-21, under 510(k) number K152257.

Who is the listed applicant for Fujifilm Duodenoscope Model ED-530XT?

The FDA 510(k) record lists Fujifilm Medical Systems U.S.A, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fujifilm Duodenoscope Model ED-530XT?

The FDA product code for Fujifilm Duodenoscope Model ED-530XT is FDT.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Outros registros que listam Fujifilm Medical Systems U.S.A, Inc. como candidato(a)

K171291FUJIFILM Bronchoscope Model EB-530P K171207FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M K173132ASPIRE Cristalle K171463ASPIRE Bellus II K163624Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600)K162749FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR

Ver todos os 16 dispositivos →

Dispositivos Relacionados (Código: FDT)

K251861FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000Fujifilm Corporation K253646Single Use Distal Cover MAJ-2315 (MAJ-2315)Olympus Medical Systems Corp.K251867EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V)Olympus Medical Systems Corp.K250701Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)Olympus Medical Systems Corp.K233942PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 )Pentax of America, Inc.K233886Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2Ambu A/S

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.